The PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers.

A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 (1000/10mg) in Healthy Male Volunteers.

A randomized, open-label, single dose, crossover study to compare the pharmacokinetic characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in healthy male volunteers.

Study Overview

• Status: Completed
• Conditions: Diabetes; Hyperlipidemias
• Intervention / Treatment: Drug: JLP-1310; Drug: "Metformin" and "Rosuvastatin" seperately

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Inha University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male volunteer, age is over 19 years Body weight is over 50 kg, The result of Body Mass Index(BMI) is not less than 18.0 kg/m2 , no more than 29.0 kg/m2.
• Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
• Subject who has the ability and willingness to participate the whole period of trial.

Exclusion Criteria:

• Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
• Subjects who are allergic to investigational drug.
• Subjects who have a medical history which can affect the clinical trial.
• 100 mmHg ≥ Systolic BP ≥ 150mmHg or 55 mmHg ≥ Diastolic BP ≥ 95 mmHg
• AST or ALT > X 2 UNL
• Total bilirubin > 2.0 mg/dL
• CK > X 2 UNL
• eGFR < 60 mL/min/1.73m2
• History of drug abuse or positive drug screening.
• Participation in other drug studies within 3 months prior to the drug administration.
• Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Period I: administration of "Metformin" and "Rosuvastatin" seperately Period II: JLP-1310	Drug: JLP-1310; administration of JLP-1310; Drug: "Metformin" and "Rosuvastatin" seperately; administration of "Metformin" and "Rosuvastatin" seperately
Experimental: Group II; Period I: JLP-1301 Period II: administration of "Metformin' and "Rosuvastatin" seperately	Drug: JLP-1310; administration of JLP-1310; Drug: "Metformin" and "Rosuvastatin" seperately; administration of "Metformin" and "Rosuvastatin" seperately

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax of Metformin and rosuvastatin	48 hours
AUCt of Metformin and rosuvastatin	48 hours

Collaborators and Investigators

• Sponsor: Jeil Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: September 27, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; Metformin
• Other Study ID Numbers: JLP-1310-104-PK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No